BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SONICFILL COMPOSITE

    MDR report key: 3191663 · Received June 26, 2013

    Report

    Report Number
    2024312-2013-00339
    Event Type
    Injury
    Date Received
    June 26, 2013
    Report Date
    June 5, 2013
    Manufacturer
    KERR CORPORATION
    Product Code
    EBF
    PMA / PMN Number
    K091023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT OR INCIDENT SPECIFICS SUCH AS NUMBER OF PATIENTS AFFECTED, AGE, GENDER, AND WEIGHT WERE NOT PROVIDED. ALTHOUGH THE DOCTOR IDENTIFIED THREE (3) DIFFERENT SHADES ASSOCIATED WITH THE BLACK SPECKS, SHE COULD NOT VERIFY WHICH SHADE WAS USED ON EACH PATIENT; THEREFORE, NO LOT NUMBERS WERE IDENTIFIED. THE LOTS INVOLVED IN THE ALLEGED INCIDENTS INCLUDE LOT NUMBERS 4613832,4613846 AND 4427291. THE DOCTOR REMOVED THE RESTORATION AND REPEATED THE PROCEDURE USING A NEW SONICFILL TIP FOR EACH OF THE PATIENTS, WITHOUT FURTHER INCIDENT. TO DATE, ALL OF THE PATIENTS ARE DOING FINE. THE PRODUCTS INVOLVED IN THE ALLEGED INCIDENTS WERE NOT RETURNED; THEREFORE, A VISUAL EVALUATION WAS PERFORMED ON RETAINED SAMPLES FROM EACH OF THE LOTS, YIELDING RESULTS WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    A DOCTOR ALLEGED THAT BETWEEN SHADES A1, B1, AND A3 FOR THE SONICFILL COMPOSITE, BLACK SPECKS WERE PRESENT AFTER LIGHT CURING DURING RESTORATIVE PROCEDURES ON MULTIPLE PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290203 SONICFILL COMPOSITE TOOTH SHADE RESIN MATERIAL EBF KERR CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R